Senior Director Medical Affairs

Panda International
BE - leuven
May 24, 2025

An international biopharmaceutical company is seeking an experienced Interim Senior Medical Director to provide medical leadership and oversight across clinical trials from Phase I to Phase III, with a focus on data integrity, patient safety, and regulatory compliance. Based in Europe, this strategic and hands-on role is ideal for a senior physician with deep experience in clinical research, preferably within immunology or SLE.

Key Details:

Start Date: ASAP
Contract Duration: 6 months
Location: Leiden / Mechelen (Remote/Hybrid)
Languages: Native-level English required
Commitment: Full-time preferred
Interview Process: Streamlined for quick onboarding

Responsibilities

Clinical Study Leadership - Act as the medical representative of the Clinical Study Team (CST), overseeing all medical aspects of clinical trials.
Medical Oversight - Monitor patient safety and data integrity, following ICH-GCP and internal standards as outlined in the Medical Monitoring and Oversight Plan.
Medical Review & Input -
Review patient data, CRFs, data listings, and study documents (protocols, SAPs, ICFs, IBs, IMPDs).
Provide medical input on CRO/vendor selection, and work closely with CROs and key opinion leaders.
Training & Support - Provide training to investigators, CRAs, and vendors, and act as a central point of contact for medical study-related questions.
Risk Management & CAPA - Participate in the Safety Management Team, assess and mitigate safety risks, and contribute to CAPA development and protocol deviation management.
Regulatory Contributions - Support regulatory submissions and external communication of results, including CSR review and publications.

Requirements

MD or MD/PhD with at least 10 years' experience in clinical research within the pharmaceutical industry.
Minimum 3 years of medical practice experience; strong foundation in clinical medicine.
Solid understanding of Phase II-III drug development, preferably in Immunology or SLE.
Demonstrated leadership in matrixed clinical development teams.
High-level strategic thinking and analytical capabilities.
Experience collaborating with regulatory authorities, CROs, and internal R&D functions.
Excellent scientific writing, communication, and presentation skills.
Fluent/native-level English (spoken and written).

Why This Role?

Leadership in High-Impact Trials - Guide the clinical strategy and execution of pivotal trials across therapeutic areas.
Regulatory Influence - Shape key documents for regulatory submissions and external scientific communication.
Strategic & Operational Blend - Combine high-level medical strategy with detailed trial oversight.
Collaborative Environment - Work with cross-functional teams and top-tier CROs and KOLs.

Interview Process

1st Interview - With Clinical Development Leadership
2nd Interview - With Medical Affairs, Regulatory, or Program Team
Start Date: ASAP

Read the full job description and apply online on the recuiter's web-site

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